drugset / Trial / NCT07251166

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of GenSci140 in Participants With Advanced Solid Tumors

NCT07251166 ↗

Phase 1 Recruiting 170 enrolled Changchun GeneScience Pharmaceutical Co., Ltd.
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a phase I, multi-center, open-label, dose-escalation (Part 1) and dose-expansion (Part 2) first-in-human study in China to evaluate the safety, tolerability, PK profile and efficacy of GenSci140 in participants with advanced solid tumors, and to determine the MTD (if any) and RDE. The dose-expansion study aims to evaluate the efficacy, safety and PK profile of GenSci140 in the treatment of ovarian cancer or other FRα-positive advanced solid tumors at different dose levels, and to select an appropriate RP2D (if applicable).

Timeline

Start
2025-12-10
Primary completion
2028-03
Completion
2028-12

Drugs

EvaluationDrugModalityDoseRoute
Subject GenSci140 Unknown — —

Indications